Clinical investigations of medical devices shall be performed: 1) By a sufficient number of intended users in a clinical environment representative of how the device will normally be used by the target patient population. 2) In accordance with the clinical investigation plan and clinical evaluation plan. 3) Under conditions of intended normal use, which includes foreseeable errors and misuse during intended operation according to the manufacturer's instructions.

1. 1
ANNEX XV - CLINICAL INVESTIGATIONS - MDR 2017/745
Intended normal conditions of use
Antonio Bartolozzi
antonio.bartolozzi@bartolozzi.it 30/10/2019

2. 2antonio.bartolozzi@bartolozzi.it
ANNEX XV - CLINICAL INVESTIGATIONS
2.4 Clinical investigations shall be performed in accordance with the
clinical investigation plan by a sufficient number of intended users and
in a clinical environment that is representative of the intended normal
conditions of use of the device in the target patient population. Clinical
investigations shall be in line with the clinical evaluation plan as
referred to in Part A of Annex XIV.
What does “intended normal condition of use” mean ?

3. 3antonio.bartolozzi@bartolozzi.it
EN 60601-1:2006 NORMAL CONDITION
3.69
NORMAL CONDITION
condition in which all means provided for protection against HAZARDS are intact
Normal conditions of use
Conditions of use in which all means
provided for protection against
HAZARDS are intact

4. 4antonio.bartolozzi@bartolozzi.it
ISO/IEC GUIDE 51:2014
3.6
intended use
use in accordance with information provided with a product or
system, or, in the absence of such information, by generally
understood patterns of usage
Intended Normal conditions of use
Conditions of use (in accordance with information provided with a product or
system, or, in the absence of such information, by generally understood patterns of
usage) in which all means provided for protection against HAZARDS are intact

5. 5antonio.bartolozzi@bartolozzi.it
EN 62366:2007
Definition 3.12 – NORMAL USE
NORMAL USE is differentiated from CORRECT USE because a USE ERROR (i.e., a slip, lapse or
mistake) can occur while attempting to use a MEDICAL DEVICE in accordance with its
instructions for use.
NORMAL USE encompasses all foreseeable USER actions when a USER is operating a
MEDICAL
DEVICE according to the MANUFACTURER’S INTENDED USE for that device. It specifically
excludes ABNORMAL USE. See also
Figure B.1. NORMAL USE is simply what is expected from a USER under normal conditions
of use, which includes actions that are either correct or in error, but not contrary to the
design intentions of the MANUFACTURER.
There are MEDICAL DEVICES that can be used safely without instructions for use, e.g.
forceps, scalpel. For such devices, NORMAL USE is established by use in accordance with
generally accepted practice.
Conditions of use in which all means provided
for protection against HAZARDS are intact

6. 6antonio.bartolozzi@bartolozzi.it
EN 62366
Intended Normal use
reasonably foreseeable
misuse +
Intended use
Unintende normal use

7. 7antonio.bartolozzi@bartolozzi.it
Clinical Investigation - Mistakes
sufficient number of intended users and in a
clinical environment that is representative of
the
You have to investigate intended Mistakes !!!!!
• Misapplication of good rule
• Application of bad rule
• Routine Violation
• Well meant «optimization»
• Improvisation in unusual circumstances